Pain in Different Office Hysteroscopy Diameter

NCT ID: NCT02939196

Last Updated: 2017-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-12-31

Brief Summary

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The purpose of the investigators'study was To compare 2 different diameter rigid hysteroscopy in vaginoscopic approach regarding pain during and after the procedure.

And to evaluate patient acceptability and tolerability in order to determine the best way to perform hysteroscopy in an outpatient setting.

Detailed Description

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Office hysteroscopy is used as diagnostic tool to investigate abnormal uterine bleeding and other diseases involving the uterine cavity one of The main limitation to its widespread use is feared from pain and low patient tolerability Narrower diameter hysteroscopy and endometrial biopsy devices are being developed to improve the acceptability of office hysteroscopy. Miniature optical systems allow performance of most diagnostic and operative hysteroscopy (after proper patient selection) in an outpatient or office setting .Flexible hysteroscopy seem to be less painful at the beginning and during the procedure ,but the optical qualities are poor Hysteroscopy is safe, feasible and accurate procedure for diagnosing intrauterine pathology.

Provision of outpatient based diagnostic and operative services are gaining prominence as a standard of cure but the experience of pain can be off-putting for patients having outpatient diagnostic hysteroscopy.

saline solution is an excellent alternative to carbon dioxide in women undergoing outpatient hysteroscopy, and there are fewer complications

Conditions

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Pain Associated Office Hysteroscopy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group(A)

2.7 mm rigid hysteroscopy.

office hysteroscopy 3.7

Intervention Type PROCEDURE

office hysteroscopy with a 3.7 -mm outer sheath

Group(B)

2.9 mm rigid hysteroscopy.

office hysteroscopy 4

Intervention Type PROCEDURE

office hysteroscopy with a4-mm outer sheath

Interventions

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office hysteroscopy 3.7

office hysteroscopy with a 3.7 -mm outer sheath

Intervention Type PROCEDURE

office hysteroscopy 4

office hysteroscopy with a4-mm outer sheath

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Woman with nulliparous cervix

Exclusion Criteria

* Pregnancy.
* female genital cancer
* Active pelvic infection
* Multipara
* patient not receiving misoprostol
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Essam Rashad Abdel-Hafeez Othman

Associate Professor, OB-GYN department-principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Essam Othman, MD

Role: PRINCIPAL_INVESTIGATOR

Assiut

Locations

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Essam Othman

Assiut, Cairo, Egypt, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Essam Othman, MD

Role: CONTACT

Facility Contacts

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Essam Othman, MD

Role: primary

002

Other Identifiers

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OH

Identifier Type: -

Identifier Source: org_study_id

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